inforMED

MULTIPLE BRANDS

Received Oct 3, 2006

Report MW4004241 · MDR key 772160

Device

Generic name

Dental/denture Adhesives

Manufacturer

*

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

CONSUMER BELIEVES THAT DENTAL ADHESIVES SHOULD NOT BE CONSIDERED MEDICAL DEVICES AND SHOULD REQUIRE LISTS ON INGREDIENTS ON THE LABELING. HE BELIEVES THEY SHOULD BE CLASSIFIED AS DRUGS SINCE THEY ARE PUT IN THE MOUTH AND THE INGREDIENTS ARE PARTIALLY SWALLOWED AND ABSORBED BY THE SKIN.